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Study on the application of Sleep and Circadian Rhythm Interventions in Perinatal Women

Study on the application of Sleep and Circadian Rhythm Interventions in Perinatal Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110459
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep and circadian rhythm in perinatal women

Interventions

Intervention group:Sleep and circadian rhythm interventions

Sponsors

School of Nursing and Rehabilitation, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Gestational age between 16 and 20 weeks; 2.Singleton pregnancy; 3.Age >= 18 years; 4. Plans to receive regular prenatal care and deliver at the study hospital; 5.Presence of at least one sleep health dimension problem according to the RU-SATED scale; 6. Has a WeChat account and is able to use a WeChat Mini Program to participate in the study; 7.Able to understand and provide informed consent to participate; 8.Has not received any non-pharmacological treatment for insomnia (e.g., massage, acupuncture, or psychological intervention) in the past six months and is not on a waiting list for other interventions.

Exclusion criteria

Exclusion criteria: 1.Presence of severe physical or psychiatric disorders before or during pregnancy (e.g., schizophrenia, bipolar disorder); 2.Current use of prescription or over-the-counter medications that may affect sleep (e.g., benzodiazepines, non-benzodiazepine hypnotics, melatonin); 3.History or current diagnosis of organic sleep disorders (e.g., obstructive sleep apnea, narcolepsy, restless legs syndrome); 4.Presence of severe pregnancy complications or comorbidities requiring hospitalization for pregnancy maintenance; 5.Currently engaged in shift or night work; 6.Suspected severe depressive symptoms (PHQ-9 >=20); 7. Suicidal ideation, indicated by a score >= 1 on item 9 of the PHQ-9; 8.Substance abuse or smoking during pregnancy; 9.Current use of medications known to affect melatonin or cortisol secretion; 10.History of transmeridian travel within the past three months.

Design outcomes

Primary

MeasureTime frame
Sleep and circadian rhythm;

Secondary

MeasureTime frame
Psychological distress;Infant development;

Countries

China

Contacts

Public ContactCao fenglin

School of Nursing and Rehabilitation, Shandong University

caofenglin2008@126.com+86 130 6509 3172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026